The reported event was inconclusive as no sample was returned for evaluation.It was unknown whether the device had met specifications.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be, "inadequate material selection, design is inadequate.¿ the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "caution: read all instructions prior to use.Indications for use: bard nasogastric sump tubes are intended to be used for: decompression of stomach by suction or aspiration of gastric contents.Short-term administration of term tube feeding, lavage fl uid and medications.Contraindications: patients with known tape or adhesive allergies.Warnings use with caution in patients with a history of head trauma, facial trauma, esophageal diseases and patients with potential for vomiting.Do not force nasogastric tube during insertions; damage to the nasal passage and mucosa and bleeding may occur.Measure insertion length carefully- excessive insertion length of tube into the stomach may lead to coiling and/or formation of tube-knot.Lubricate the tube generously with water soluble lubricant prior to insertion.Do not use petroleum-based products as they may be harmful to the respiratory tract.Reflux of gastric contents into the blue vent lumen indicates that the suction lumen is obstructed or suction is too low.Routinely check for reflux in the blue vent lumen and clear as per applicable directions.Failure to clear the obstruction or clear prevent® filter may cause gas and fluid buildup in stomach, aspiration of gastric contents, aspiration pneumonia and other complications.Do not inject fluid through the prevent® filter as this may result in blockage and leakage of filter.Monitor patient for nasal erosion, sinusitis, esophagitis, esophagotracheal fistula, gastric erosion and pulmonary & oral infections.Statlock® nasogastric stabilization device: avoid contact with alcohol or acetone; both can weaken bonding of components and statlock® stabilization device pad adherence.Instructions for nasogastric tube insertion explain the procedure to the patient.Carefully measure to fi nd desired length of the tube using the nasogastric tube as a measurement aid.To determine the insertion length: measure the tube from the tip of the nose to the earlobe and from the earlobe to the tip of the xiphoid process.Mark the length of the tube to be passed with a small piece of tape.Check the patient¿s nostrils for patency; select the nostril with best patency.Lubricate the full length of tube to be inserted.Released." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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